Development and Validation of the FBIndex to Determine the Risk of Falls for Patients With Neuromuscular Disorders

Sponsor
LMU Klinikum
Study ID
NCT06605612
Status
Enrolling By Invitation

Conditions

  • Amyotrophic Lateral Sclerosis
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Friedreich Ataxia
  • Guillain-Barré Syndrome
  • Hereditary Motor Sensory Neuropathy
  • Inclusion Body Myositis
  • Lambert-Eaton-Syndrome
  • Limb-girdle and Facioscapulohumeral Muscular Dystrophies
  • Myasthenia Gravis
  • Myotonic Dystrophy
  • Pompe Disease
  • Spinal Muscular Atrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • FBIndex — DIAGNOSTIC_TEST
    There will be no intervention.

Study Details

Currently, there are no standardised fall risk scores or guidelines on when to use appropriate assistive gait devices (AGDs) for people with neuromuscular disorders (NMDs). There is a clear medical unmet need to provide a battery of appropriate locomotor gait assessments to determine the risk of falling for patients with NMDs and give clear guidelines to prescribe an appropriate AGD. The primary goal is to confirm whether the clinical battery assessments (Heel-Rise Test (HRT), Chair-Rise Test (CRT), Semi-tandem Stand (STS), Trunk-Rise Test (TRT), Foot-Tapping Test (FTT), Timed Up and Go (TUG), 10-Meter-Walk Test (10MWT) and 6-Minute-Walk Test (6MWT) can be validated and generalized to other NMD target populations that meet broader eligibility criteria based on used clinical assessments. The second objective of this project is to provide intra- and inter-observer reliability and test-retest reliability of included clinical assessments used to determine the risk of falling for patients with NMDs. Finally, all data will be compared with norm data from the healthy population (n=15) collected retrospectively.

Key Dates

Start date
Sep 9, 2024
Status verified
Sep 2025
Primary completion
Aug 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
108 participants (estimated)

Arms

  • Arm: Friedrich-Baur-Institute
    All patients in group A will undergo single tests (cross-over design data):HRT, CRT, STS, FTT and TRT on the Leonardo Mechanograph® Ground Reaction Force Plate, assessing power and force data. Additionally, the time to perform the tests will be assessed manually. The 10MWT, 6MWT and TUG tests are performed without a ground reaction force plate and only time parameters are assessed. The group A will have an additional subgroup A1 of n=20 patients, which will be tested two times within two weeks to confirm intra-rater (n=10) and inter-rater reliability (n=10).No intervention will be carried out.
  • Arm: Medical Park Bad Feilnbach
    The group B will perform the same tests without using a force plate, assessing only the time parameters. No intervention will be carried out.

Primary Outcome Measure

Chair-Rise Test (CRT) [ Time Frame: Immediately after the ICF is signed ]

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